Z-1927-2013Class II

Invue Split Driver, Assembly with Handle, Model SI70006 Rev G. Used in conjunction with the Invue Anterior...

Name: Z-1927-2013 Invue Split Driver, Assembly with Handle, Model SI70006 Rev G. Used in conjunction with the Invue Anterior...
Creator: SpineFrontier, Inc.
Published: 2013-05-10
License: https://open.fda.gov/license/

SPINEFRONTIER, Inc. dba LESspine Innovations / initiated 2013-05-10 / Terminated / root cause: design

FDA source

SpineFrontier, Inc. began a recall of Invue Split Driver, Assembly with Handle, Model SI70006 Rev G. Used in conjunction with the Invue Anterior Cervical Plate System under 501(k) clearance number... on 2013-05-10. FDA classified it as Class II and gives the reason as "Device design". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1927-2013
Classification: Class II
Status: Terminated
Initiated: 2013-05-10
Posted: 2013-08-08
Terminated: 2015-07-20
Recalling firm: SPINEFRONTIER, Inc. dba LESspine Innovations
Product: Invue Split Driver, Assembly with Handle, Model SI70006 Rev G. Used in conjunction with the Invue Anterior Cervical Plate System under 501(k) clearance number K121060. The Invue Driver is an instrument consisting of a Radel handle, a shaft and hexalobe-like tip with a 4.0mm split, which allows the driver to collapse to fit into a screw and expand to retain the screw.
Product code: HXX Screwdriver
Reason for recall: Device design.
Root cause tag: design
FDA root cause: Device Design
Action: SpineFrontier sent an URGENT Advisory Notice dated June 27, 2013, to all affected consignees regarding the use of Invue Drivers. The notice advises users that the Split Tip Stylet Driver Assembly (11-70099) and Sold Driver, AO Connection (11-70070 or 11-70077) are being shipped in place of the Split Driver Assembly w/Handle (SI70006). The uses of the replacement parts are explained. Consignees are instructed to complete the Acknowledgement Form and return it to SpineFrontier. On June 28, 2013, customers were sent a second Advisory Notice requesting the removal of the Split Driver Assy w/ Handle Part Number SI70006 Lot Numbers 027104 and 027105. Consignees were instructed to complete the Acknowledgement Form and return it to SpineFrontier. Consignees with questions were instructed to call 978-232-3990.
Quantity in commerce: 12 devices
Distribution: Nationwide Distribution including Texas, Ohio, and Missouri.
Product codes and lots: Lot/Serial Numbers: 027104, 027105

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1927-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1927-2013	Class II	Terminated	Voluntary: Firm initiated	2013-08-14	2013-08-08

Product code HXX

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)